GUDIDData
eudamed_udi Primary ID: 05430002895765

Elastus Sigmafilm (UDI 05430002895765)

Manufactured by Reskin Medical NV

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Elastus Sigmafilm - Primary ID 05430002895765

Device Regulatory Overview

The Elastus Sigmafilm (Model/Catalog Number: 72643) is a medical device manufactured by Reskin Medical NV. This product is indexed under FDA Product Code / Category Classification M04040601 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
72643
Product Code / EMDN
M04040601
Device Name
Sigma Film
Database Sync Date
2026-08-09 16:44:56

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Elastus Sigmafilm?

The registered manufacturer of record for Elastus Sigmafilm is Reskin Medical NV.

What is the Primary UDI-DI identifier for Elastus Sigmafilm?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05430002895765.

What classification code is assigned to this device?

This device is registered under product classification code M04040601.

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